Who is eligible for clinical trial NCT06876935?

Participants must meet the protocol's inclusion criteria for Gut Microbiome. The stated age range is 3 Months to 6 Months. Confirm all requirements with the study coordinator.

Does clinical trial NCT06876935 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-08-21

Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants (NCT06876935)

Guac & Grow: Early Avocado Exposure on Development and the Gut Microbiome in American Hispanic Infants

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: Arizona State University

🩺 Plain-English Summary (8th-Grade Level)

The goal of this clinical trial is to learn if daily avocado intake can improve growth and brain and gut health in infants. The main questions it aims to answer are: Does daily eating of avocados change which microbes live in the infant's gut? Does daily avocado intake improve infant motor skills and cognitive development? Researchers will compare avocado intake to standard of care (no or limited avocado intake) to see if regular avocado intake from 6-12 months of life influences gut and brain health. Participating mothers/guardians and their infants will: Parents will provide avocado or no avocado to their infant every day for 6 months starting around 6 months of infant age. Parents will allow study staff to visit participant homes to collect data via surveys and observations and measure infant growth. Parents will swab soiled infant diapers for gut microbe measures. Parents will keep a diary of the infant's avocado consumption and acceptance of the food. Parents will record their infant's dietary intake

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (6 items).

Location: College of Health Solutions — Phoenix, Arizona

Age range: 3 Months to 6 Months

🧪 Interventions in This Study

Daily avocado (OTHER)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

4-6-month-old Hispanic/Latine, non-preterm (\>37 weeks gestation) singleton infants
Infants born to mothers 18 years and older while pregnant
Parents speak English and/or Spanish
Families willing to begin feeding infants avocado around 6 months of age or when the infant is ready for solids for a total of 6 months
Family history of food or latex allergies will be evaluated as avocado is a latex fruit and can cause allergic responses. If either mom or dad is allergic to avocado, physician clearance for infant participation will be needed.
At least one caregiver in the home must have at least an 8th-grade education level

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Infants with growth, chromosomal, or genetic abnormality, developmental and cognitive impairments, or severe comorbidity that could impact growth and development
Infants born with congenital abnormalities or developmental delays
Infant birth weights \<2500 g or \>4000 g
Infants introduced to solid foods prior to 3 months of age
Biological mothers with known substance use during pregnancy (alcohol, tobacco, marijuana, or illegal drugs), or who experienced a high-risk pregnancy (e.g., preeclampsia, diabetes-Types 1 and 2 and gestational, HIV, etc.)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

College of Health Solutions — Phoenix, Arizona

📞 Contact the Study Coordinator

Phone: (602) 496-3348

Email: cwhisner@asu.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗